Perioperative Pembrolizumab (MK-3475) Plus Neoadjuvant Chemotherapy Versus Perioperative Placebo Plus Neoadjuvant Chemotherapy for Cisplatin-eligible Muscle-invasive Bladder Cancer (MIBC) (MK-3475-866/KEYNOTE-866)
NCT ID: NCT03924856
Last Updated: 2025-08-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE3
907 participants
INTERVENTIONAL
2019-06-13
2026-09-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Pembrolizumab + Gemcitabine + Cisplatin + Surgery
Participants received 4 preoperative cycles of pembrolizumab PLUS gemcitabine PLUS cisplatin, followed by surgery, followed by up to 13 cycles of postoperative pembrolizumab.
Pembrolizumab
Pembrolizumab 200 mg by intravenous (IV) infusion, given on Day 1 of each 21-day cycle
Gemcitabine
Gemcitabine 1000 mg/m\^2, IV infusion on Days 1 and 8 of each 21-day cycle
Cisplatin
Cisplatin 70 mg/m\^2, IV infusion on Day 1 of each 21-day cycle
Surgery (radical cystectomy (RC) plus Pelvic Lymph Node Dissection [PLND])
Surgical RC+PLND will be done in accordance with the American Urological Association (AUA)/American Society of Clinical Oncology (ASCO)/American Society for Radiation Oncology (ASTRO)/Society of Urologic Oncology (SUO) guidelines.
Placebo + Gemcitabine + Cisplatin + Surgery
Participants received 4 preoperative cycles of placebo to pembrolizumab PLUS gemcitabine PLUS cisplatin, followed by surgery, followed by up to 13 cycles of postoperative placebo to pembrolizumab.
Gemcitabine
Gemcitabine 1000 mg/m\^2, IV infusion on Days 1 and 8 of each 21-day cycle
Cisplatin
Cisplatin 70 mg/m\^2, IV infusion on Day 1 of each 21-day cycle
Surgery (radical cystectomy (RC) plus Pelvic Lymph Node Dissection [PLND])
Surgical RC+PLND will be done in accordance with the American Urological Association (AUA)/American Society of Clinical Oncology (ASCO)/American Society for Radiation Oncology (ASTRO)/Society of Urologic Oncology (SUO) guidelines.
Placebo
Placebo to pembrolizumab by IV infusion, given on Day 1 of each 21-day cycle
Interventions
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Pembrolizumab
Pembrolizumab 200 mg by intravenous (IV) infusion, given on Day 1 of each 21-day cycle
Gemcitabine
Gemcitabine 1000 mg/m\^2, IV infusion on Days 1 and 8 of each 21-day cycle
Cisplatin
Cisplatin 70 mg/m\^2, IV infusion on Day 1 of each 21-day cycle
Surgery (radical cystectomy (RC) plus Pelvic Lymph Node Dissection [PLND])
Surgical RC+PLND will be done in accordance with the American Urological Association (AUA)/American Society of Clinical Oncology (ASCO)/American Society for Radiation Oncology (ASTRO)/Society of Urologic Oncology (SUO) guidelines.
Placebo
Placebo to pembrolizumab by IV infusion, given on Day 1 of each 21-day cycle
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Have clinically non-metastatic bladder cancer (N≤1 M0) determined by imaging (computed tomography (CT) or magnetic resonance imaging (MRI)) of the chest/abdomen/pelvis.
* Be deemed eligible for Radical Cystectomy (RC) + Pelvic Lymph Node Dissection (PLND).
* Have Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
* Have adequate organ function.
* Male and female participants are eligible to participate if they agree to the contraception use as per study protocol.
Exclusion Criteria
* Has received any prior systemic treatment for MIBC or non-invasive muscle bladder cancer (NMIBC - prior treatment for NMIBC with intravesical BCG/chemotherapy is permitted) or prior therapy with an anti- programmed cell death 1 (PD-1), anti-programmed cell death ligand 1/ ligand 2 (PD-L1/L2), or anti-cytotoxic T-lymphocyte-associated protein 4 (CTLA-4).
* Has ≥N2 disease or metastatic disease (M1) as identified by imaging.
* Is cisplatin-ineligible, as defined by meeting any one of the cisplatin ineligibility criteria as per protocol.
* Has received prior systemic anticancer therapy including investigational agents within 3 years of randomization or any radiotherapy to the bladder.
* Has undergone partial cystectomy of the bladder to remove any NMIBC or MIBC.
* Has received a live or live attenuated vaccine within 30 days before the first dose of study intervention.
* Has a diagnosis of immunodeficiency or has a known history of human immunodeficiency virus (HIV) infection, Hepatitis B infection or known active Hepatitis C infection.
* Has a known psychiatric or substance abuse disorder.
* Has had an allogenic tissue/solid organ transplant.
18 Years
ALL
No
Sponsors
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Merck Sharp & Dohme LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Merck Sharp & Dohme LLC
Locations
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Scripps MD Anderson ( Site 0010)
La Jolla, California, United States
Providence Saint John's Health Center ( Site 0075)
Santa Monica, California, United States
Georgetown University Medical Center ( Site 0022)
Washington D.C., District of Columbia, United States
AdventHealth Orlando-AdventHealth Medical Group Hematology & Oncology at Orlando ( Site 0005)
Orlando, Florida, United States
Parkview Cancer Institute ( Site 0077)
Fort Wayne, Indiana, United States
Indiana University Melvin and Bren Simon Cancer Center ( Site 0004)
Indianapolis, Indiana, United States
Ochsner Medical Center ( Site 0049)
New Orleans, Louisiana, United States
New England Cancer Specialists ( Site 0070)
Scarborough, Maine, United States
UMass Memorial Medical Center ( Site 0051)
Worcester, Massachusetts, United States
Henry Ford Hospital ( Site 0039)
Detroit, Michigan, United States
Mercy Hospital Saint Louis ( Site 0064)
St Louis, Missouri, United States
Morristown Medical Center ( Site 0015)
Morristown, New Jersey, United States
UNM Comprehensive Cancer Center-Clinical Research Office ( Site 0045)
Albuquerque, New Mexico, United States
New York University Perlmutter Cancer Center ( Site 0008)
New York, New York, United States
University Hospitals Cleveland Medical Center ( Site 0038)
Cleveland, Ohio, United States
Oklahoma Cancer Specialists and Research Institute, LLC ( Site 0021)
Tulsa, Oklahoma, United States
Portland VA Medical Center ( Site 0084)
Portland, Oregon, United States
Allegheny General Hospital ( Site 0048)
Pittsburgh, Pennsylvania, United States
MD Anderson Cancer Center ( Site 0063)
Houston, Texas, United States
Central Texas Veterans Healthcare System ( Site 0057)
Temple, Texas, United States
Inova Schar Cancer Institute ( Site 0007)
Fairfax, Virginia, United States
Northwest Medical Specialties, PLLC ( Site 0061)
Puyallup, Washington, United States
Seattle Cancer Care Alliance/Univ of Washington Medical Center ( Site 0033)
Seattle, Washington, United States
Charleston Area Medical Center ( Site 0023)
Charles Town, West Virginia, United States
Mid North Coast Cancer Institute ( Site 1256)
Port Macquarie, New South Wales, Australia
Southside Cancer Care Centre ( Site 1252)
Sydney, New South Wales, Australia
Cairns Base Hospital ( Site 1257)
Cairns, Queensland, Australia
Eastern Health ( Site 1255)
Box Hill, Victoria, Australia
Peninsula Health Frankston Hospital ( Site 1258)
Frankston, Victoria, Australia
UZ Brussel ( Site 0358)
Brussels, Bruxelles-Capitale, Region de, Belgium
Jessa Ziekenhuis ( Site 0360)
Hasselt, Limburg, Belgium
CHU UCL Namur Site de Godinne ( Site 0354)
Yvoir, Namur, Belgium
O.L.V. Ziekenhuis Aalst ( Site 0356)
Aalst, Oost-Vlaanderen, Belgium
AZ Maria Middelares Gent ( Site 0353)
Ghent, Oost-Vlaanderen, Belgium
Tom Baker Cancer Centre ( Site 0100)
Calgary, Alberta, Canada
Nova Scotia Health Authority ( Site 0109)
Halifax, Nova Scotia, Canada
Kingston Health Sciences Centre ( Site 0103)
Kingston, Ontario, Canada
Lakeridge Health ( Site 0104)
Oshawa, Ontario, Canada
Sunnybrook Research Institute ( Site 0110)
Toronto, Ontario, Canada
Princess Margaret Cancer Centre ( Site 0107)
Toronto, Ontario, Canada
CIUSSS de l Est de L Ile de Montreal - Hopital Maisonneuve-Rosemont ( Site 0105)
Montreal, Quebec, Canada
Centre intégré de cancérologie du CHU de Québec Université Laval, Hôpital de l'Enfant-Jésus ( Site 0
Québec, Quebec, Canada
Rigshospitalet University Hospital ( Site 0401)
Copenhagen, Capital Region, Denmark
Herlev og Gentofte Hospital. ( Site 0402)
Herlev, Capital Region, Denmark
Odense Universitetshospital ( Site 0403)
Odense, Region Syddanmark, Denmark
CHU de Bordeaux- Hopital Saint Andre ( Site 0456)
Bordeaux, Aquitaine, France
Centre Leon Berard ( Site 0465)
Lyon, Auvergne, France
Centre Francois Baclesse ( Site 0459)
Caen, Calvados, France
Centre Armoricain de Radiotherapie Imagerie medicale et Oncologie ( Site 0457)
Plérin, Cotes-d Armor, France
Hopital Foch ( Site 0483)
Suresnes, Hauts-de-Seine, France
CHU de Montpellier - Hopital Saint-Eloi ( Site 0469)
Montpellier, Languedoc-Roussillon, France
Institut de Cancerologie de l Ouest Site Paul Papin ( Site 0453)
Angers, Maine-et-Loire, France
Hopital Robert Schuman ( Site 0452)
Metz, Moselle, France
Centre Jean Perrin ( Site 0460)
Clermont-Ferrand, Puy-de-Dome, France
Clinique Victor Hugo ( Site 0463)
Le Mans, Sarthe, France
CHU de Rouen ( Site 0493)
Rouen, Seine-Maritime, France
Institut Sainte Catherine ( Site 0454)
Avignon, Vaucluse, France
Klinikum der Eberhard-Karls-Universitaet Tuebingen ( Site 0502)
Tübingen, Baden-Wurttemberg, Germany
Universitaetsklinikum Erlangen ( Site 0505)
Erlangen, Bavaria, Germany
Universitaetsklinikum Carl Gustav Carus ( Site 0519)
Dresden, Saxony, Germany
Universitaetsklinikum Magdeburg A.o.R. ( Site 0516)
Magdeburg, Saxony-Anhalt, Germany
Universitaetsklinikum Schleswig-Holstein-Campus Lubeck ( Site 0512)
Lübeck, Schleswig-Holstein, Germany
Charite Universitaetsmedizin Berlin ( Site 0515)
Berlin, , Germany
Vivantes Klinikum am Urban ( Site 0522)
Berlin, , Germany
Pecsi Tudomanyegyetem AOK ( Site 1009)
Pécs, Baranya, Hungary
SZTE Szent-Gyorgyi Albert Klinikai Kozpont ( Site 1010)
Szeged, Csongrád megye, Hungary
Jasz Nagykun Szolnok Megyei Hetenyi Geza Korhaz Rendelointezet ( Site 1002)
Szolnok, Jász-Nagykun-Szolnok, Hungary
Bajcsy Zsilinszki Korhaz es Rendelointezet ( Site 1001)
Budapest, , Hungary
Debreceni Egyetem Klinikai Kozpont ( Site 1006)
Debrecen, , Hungary
Petz Aladar Megyei Oktato Korhaz ( Site 1012)
Győr, , Hungary
Somogy Megyei Kaposi Mor Oktato Korhaz ( Site 1007)
Kaposvár, , Hungary
Cork University Hospital ( Site 0722)
Cork, , Ireland
Tallaght University Hospital ( Site 0710)
Dublin, , Ireland
University Hospital Waterford ( Site 0723)
Waterford, , Ireland
Ha Emek Medical Center ( Site 0808)
Afula, , Israel
Soroka Medical Center ( Site 0806)
Beersheba, , Israel
Rambam Health Care Campus-Oncology Division ( Site 0802)
Haifa, , Israel
Shaare Zedek Medical Center ( Site 0809)
Jerusalem, , Israel
Hadassah Ein Kerem Medical Center ( Site 0810)
Jerusalem, , Israel
Meir Medical Center ( Site 0803)
Kfar Saba, , Israel
Rabin Medical Center ( Site 0804)
Petah Tikva, , Israel
Sheba Medical Center ( Site 0801)
Ramat Gan, , Israel
Sourasky Medical Center ( Site 0807)
Tel Aviv, , Israel
Yitzhak Shamir Medical Center ( Site 0805)
Ẕerifin, , Israel
Policlinico Gemelli di Roma ( Site 0558)
Roma, Abruzzo, Italy
Policlinico di Modena ( Site 0553)
Modena, Emilia-Romagna, Italy
A.O.U. Policlinico Vittorio Emanuele - Presidio Gaspare Rodolico ( Site 0559)
Catania, , Italy
Istituto Nazionale Studio e Cura dei Tumori ( Site 0551)
Milan, , Italy
Istituto Nazionale Per Lo Studio E La Cura Dei Tumori ( Site 0552)
Napoli, , Italy
Fondazione Salvatore Maugeri IRCCS. ( Site 0554)
Pavia, , Italy
Azienda Ospedaliera San Camillo Forlanini ( Site 0560)
Roma, , Italy
Azienda Ospedaliera Santa Maria Terni ( Site 0557)
Terni, , Italy
Hirosaki University Hospital ( Site 1502)
Hirosaki, Aomori, Japan
National Cancer Center Hospital East ( Site 1504)
Kashiwa, Chiba, Japan
Ehime University Hospital ( Site 1508)
Tōon, Ehime, Japan
Sapporo Medical University Hospital ( Site 1501)
Sapporo, Hokkaido, Japan
University of Tsukuba Hospital ( Site 1503)
Tsukuba, Ibaraki, Japan
Yokosuka Kyosai Hospital ( Site 1509)
Yokosuka, Kanagawa, Japan
Nara Medical University Hospital ( Site 1510)
Kashihara, Nara, Japan
Saitama Medical University International Medical Center ( Site 1505)
Hidaka, Saitama, Japan
Chiba Cancer Center ( Site 1506)
Chiba, , Japan
Harasanshin Hospital ( Site 1515)
Fukuoka, , Japan
Hiroshima City Hiroshima Citizens Hospital ( Site 1513)
Hiroshima, , Japan
Nagano Municipal Hospital ( Site 1516)
Nagano, , Japan
Osaka Metropolitan University Hospital ( Site 1512)
Osaka, , Japan
Tokushima University Hospital ( Site 1514)
Tokushima, , Japan
Tokyo Medical and Dental University Hospital ( Site 1517)
Tokyo, , Japan
Centro de Urologia Avanzada del Noreste S.A. de C.V. ( Site 0254)
Monterrey, Nuevo León, Mexico
Investigacion Biomedica para el Desarrollo de Farmacos S.A. de C.V. ( Site 0300)
Aguascalientes, , Mexico
Centro Estatal de Cancerologia de Chihuahua ( Site 0253)
Chihuahua City, , Mexico
Instituto Nacional de Cancerologia ( Site 0256)
Tlalpan, , Mexico
Centrum Onkologii im.prof. F. Lukaszczyka w Bydgoszczy ( Site 1068)
Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland
Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego ( Site 1062)
Wroclaw, Lower Silesian Voivodeship, Poland
Europejskie Centrum Zdrowia Otwock ( Site 1057)
Otwock, Masovian Voivodeship, Poland
Luxmed Onkologia sp. z o. o. ( Site 1051)
Warsaw, Masovian Voivodeship, Poland
Beskidzkie Centrum Onkologii im. Jana Pawla II ( Site 1060)
Bielsko-Biala, Silesian Voivodeship, Poland
Clinic of Bashkortostan State Medical University ( Site 0869)
Ufa, Baskortostan, Respublika, Russia
Ivanovo Regional Oncology Dispensary ( Site 0852)
Ivanovo, Ivanovo Oblast, Russia
Krasnoyarsk Regional Clinical Oncological Dispensary ( Site 0861)
Krasnoyarsk, Krasnoyarsk Krai, Russia
Kursk Regional Clinical Oncology Dispensary ( Site 0854)
Kursk, Kursk Oblast, Russia
FSBI ""United Hospital with Polyclinic"" of the Administrative Department of the President of the Ru
Moscow, Moscow, Russia
Central Clinical Hospital with outpatient Clinic ( Site 0856)
Moscow, Moscow, Russia
Bayandin Murmansk Regional Clinical Hospital ( Site 0859)
Murmansk, Murmansk Oblast, Russia
Volga District Medical Center Federal Medical and Biological Agency ( Site 0857)
Nizhny Novgorod, Nizhny Novgorod Oblast, Russia
Omsk Clinical Oncology Dispensary ( Site 0865)
Omsk, Omsk Oblast, Russia
Leningrad Regional Oncology Center ( Site 0868)
Saint Petersburg, Sankt-Peterburg, Russia
Clinical Hospital Saint Luka ( Site 0867)
Saint Petersburg, Sankt-Peterburg, Russia
Saratov State Medical University n.a. V.I.Razumovskiy ( Site 0866)
Saratov, Saratov Oblast, Russia
National Cancer Center ( Site 1354)
Goyang-si, Kyonggi-do, South Korea
Seoul National University Bundang Hospital ( Site 1356)
Seongnam-si, Kyonggi-do, South Korea
Korea University Anam Hospital ( Site 1351)
Seoul, , South Korea
Seoul National University Hospital ( Site 1352)
Seoul, , South Korea
Asan Medical Center ( Site 1355)
Seoul, , South Korea
Samsung Medical Center ( Site 1353)
Seoul, , South Korea
Hospital San Pedro de Alcantara ( Site 0654)
Cáceres, Extremadura, Spain
H. de Gerona Dr. Josep Trueta ( Site 0651)
Girona, Gerona, Spain
Hospital Universitario Ramon y Cajal ( Site 0660)
Madrid, Madrid, Comunidad de, Spain
Hospital Universitario Quiron Madrid ( Site 0657)
Pozuelo de Alarcón, Madrid, Comunidad de, Spain
Instituto Valenciano de Oncologia - IVO ( Site 0662)
Valencia, Valenciana, Comunitat, Spain
Hospital del Mar ( Site 0653)
Barcelona, , Spain
Hospital Universitario San Carlos ( Site 0663)
Madrid, , Spain
Hospital Universitario La Paz ( Site 0661)
Madrid, , Spain
Hospital Nuestra Sra. de Valme ( Site 0658)
Seville, , Spain
Laenssjukhuset Ryhov ( Site 1205)
Jönköping, Jönköping County, Sweden
Akademiska Sjukhuset ( Site 1201)
Uppsala, Uppsala County, Sweden
Cancercentrum ( Site 1204)
Umeå, Västerbotten County, Sweden
Ramathibodi Hospital. ( Site 1451)
Bangkok, Bangkok, Thailand
Faculty of Medicine Siriraj Hospital ( Site 1452)
Bangkok, Bangkok, Thailand
Maharaj Nakorn Chiangmai Hospital ( Site 1453)
Chiang Mai, , Thailand
Srinagarind Hospital ( Site 1454)
Khon Kaen, , Thailand
Hacettepe Universitesi Tıp Fakultesi ( Site 0911)
Ankara, , Turkey (Türkiye)
Istanbul Universitesi Cerrahpasa Tip Fakultesi ( Site 0910)
Istanbul, , Turkey (Türkiye)
TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi-oncology ( Site 0906)
Istanbul, , Turkey (Türkiye)
Universitesi Pendik Egitim ve Arastirma Hastanesi ( Site 0901)
Istanbul, , Turkey (Türkiye)
Necmettin Erbakan Universitesi Meram Tip Fakultesi Hastanesi ( Site 0909)
Konya, , Turkey (Türkiye)
Sakarya Universitesi Tip Fakultesi ( Site 0913)
Sakarya, , Turkey (Türkiye)
Karadeniz Teknik Universitesi Tip Fakultesi Farabi Hastanesi ( Site 0904)
Trabzon, , Turkey (Türkiye)
Cherkasy Regional Oncology Dispensary ( Site 0959)
Cherkasy, Cherkasy Oblast, Ukraine
Regional Oncological Hospital ( Site 0956)
Dnipro, Dnipropetrovsk Oblast, Ukraine
Dnipropetrovsk City Multidiscipline Clinical Hosp. 4 of DRC ( Site 0951)
Dnipro, Dnipropetrovsk Oblast, Ukraine
MI Dnipr Regional Clinical Hospital named after I.I. Mechnikov ( Site 0963)
Dnipropetrovsk, Dnipropetrovsk Oblast, Ukraine
Reg. Clinical Center of Urology and Nephrology n.a. V. I. Shapoval ( Site 0969)
Kharkiv, Kharkivs’ka Oblast’, Ukraine
CNPE "Regional Center of Oncology" ( Site 0958)
Kharkiv, Kharkivs’ka Oblast’, Ukraine
National Cancer Institute of the MoH of Ukraine ( Site 0962)
Kyiv, Kyivska Oblast, Ukraine
Lviv Regional Clinical Hospital ( Site 0955)
Lviv, Lviv Oblast, Ukraine
Lviv State Oncology Regional Treatment and Diagnostic Center ( Site 0967)
Lviv, Lviv Oblast, Ukraine
Kyiv City Clinical Oncology Center ( Site 0960)
Kyiv, , Ukraine
Aberdeen Royal Infirmary ( Site 0708)
Aberdeen, Aberdeen City, United Kingdom
Torbay Hospital ( Site 0704)
Torquay, Devon, United Kingdom
Kent and Canterbury Hospital ( Site 0709)
Canterbury, England, United Kingdom
Lister Hospital ( Site 0715)
Stevenage, Hertfordshire, United Kingdom
The Royal Marsden Foundation Trust ( Site 0702)
London, London, City of, United Kingdom
Imperial College Healthcare NHS Trust ( Site 0721)
London, London, City of, United Kingdom
Norfolk & Norwich University Hospital NHS Foundation Trust ( Site 0725)
Norwich, Norfolk, United Kingdom
Royal Cornwall Hospital ( Site 0703)
Truro, , United Kingdom
Countries
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References
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Galsky MD, Hoimes CJ, Necchi A, Shore N, Witjes JA, Steinberg G, Bedke J, Nishiyama H, Fang X, Kataria R, Sbar E, Jia X, Siefker-Radtke A. Perioperative pembrolizumab therapy in muscle-invasive bladder cancer: Phase III KEYNOTE-866 and KEYNOTE-905/EV-303. Future Oncol. 2021 Aug;17(24):3137-3150. doi: 10.2217/fon-2021-0273. Epub 2021 May 19.
Related Links
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Merck Clinical Trials Information
Plain Language Summary
Other Identifiers
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MK-3475-866
Identifier Type: OTHER
Identifier Source: secondary_id
KEYNOTE-866
Identifier Type: OTHER
Identifier Source: secondary_id
2080224790
Identifier Type: REGISTRY
Identifier Source: secondary_id
2022-501970-20-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
194870
Identifier Type: REGISTRY
Identifier Source: secondary_id
U1111-1282-6279
Identifier Type: REGISTRY
Identifier Source: secondary_id
2018-003808-39
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
3475-866
Identifier Type: -
Identifier Source: org_study_id
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